Back to School: How biopharma can reboot drug development. Access exclusive analysis here

0824 Podcast EUA
BioCentury & Getty Images

Regulation

Politics & plasma: a BioCentury podcast

Aug 25, 2020 | 1:30 AM GMT

Ex-FDA officials are mixed on the merits of an agency decision to grant an EUA for COVID-19 convalescent plasma, but there is widespread agreement that the process was marred by political posturing, including statements by President Donald Trump and top HHS officials exaggerating the strength of the supporting evidence. On the latest edition of the BioCentury This Week podcast, BioCentury’s editors discuss the ramifications of the decision to grant the Emergency Use Authorization, as well as PhRMA’s drug pricing proposal and Merck’s selection of London for its newest discovery hub.

Washington Editor Steve Usdin, Editor in Chief Simone Fishburn and Executive Editor Jeff Cranmer discuss the takeaways from BioCentury’s conversations with former senior FDA officials, many of whom say that FDA Commissioner Stephen Hahn’s decisions and comments have put politics ahead of science. Usdin says that Trump’s accusations that FDA has delayed COVID-19 regulatory decisions to harm his election chances has created a stain on the agency that could be difficult to erase (see “Ex-FDA Officials: EUA May Be Merited, But FDA Put Politics Ahead of Science”).

Usdin also provides details on PhRMA’s proposed package of drug cost control measures that are intended as an alternative to the Trump administration’s “most favored nation” Executive Order. Negotiated with White House Chief of Staff Mark Meadows, the plan would create $135-$150 billion in savings over 10 years (see “Proposal to Fend Off ‘Most Favored Nation’).

Fishburn says a decision by Merck & Co. Inc. (NYSE:MRK) to build its new Discovery Research Centre in London underscores the U.K.’s growing importance as a global hub for life sciences innovation even in the face of Brexit (see “Merck’s North London Pick”).

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE